Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies
|ClinicalTrials.gov Identifier: NCT01745081|
Recruitment Status : Unknown
Verified December 2012 by Stéphane Coutu, Centre Hospitalier Universitaire de Sherbrooke.
Recruitment status was: Recruiting
First Posted : December 7, 2012
Last Update Posted : December 7, 2012
Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.
This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.
Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.
|Condition or disease||Intervention/treatment||Phase|
|Osmotherapy Intracranial Pressure||Drug: 20% mannitol bolus administration Drug: Hypertonic saline 3% bolus administration||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||September 2014|
Bolus mannitol 20% at skin incision
|Drug: 20% mannitol bolus administration|
Experimental: Hypertonic saline
Hypertonic saline 3% at skin incision
|Drug: Hypertonic saline 3% bolus administration|
- Sub-dural intracranial pressure [ Time Frame: In average 30-60 minutes after intervention, just before dura mater opening ]Sub-dural measure of intracranial pressure to evaluate cerebral relaxation
- Subjective evaluation of cerebral relaxation [ Time Frame: In average 30-60 minutes after intervention, just after dura mater opening ]Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale
- Serum lactate [ Time Frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit ]Serum lactate measurement to assess tissue perfusion during the procedure
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745081
|Contact: Stéphane Coutu, MD, FRCPC||8193461110 ext email@example.com|
|Centre hospitalier universitaire de Sherbrooke||Recruiting|
|Sherbrooke, Quebec, Canada, J1H5N4|